European Journal of Chemistry

Stability-indicating methods for the determination of olanzapine in presence of its degradation products



Main Article Content

Lobna Abd El Aziz Hussien
Maha Farouk Abdel Ghani
Amal Mahmoud Abo El-Alamein
Ekram Hany Mohamed

Abstract

Simple, sensitive and precise spectrophotometric and chemometric stability indicating techniques were adopted for Olanzapine (OLA) determination in presence of its degradation products over a concentration range of 0.002-0.02 mg/mL. The spectrophotometric technique involves six methods; first method is first derivative (D1) spectrophotometric one, which allows the determination of OLA in presence of its acidic and alkaline degradation products at 261.2 and 260.6 nm with mean percentage recoveries of 99.90±0.48 and 99.95±0.67, respectively. While second derivative spectrophotometry (D2) was used for determination of drug in presence of alkaline degradation products. Second method is first-derivative of the ratio spectra (DR1) for determination of OLA in presence of its acidic and alkaline degradation products at 267.9 and 251.6 nm, respectively with mean percentage recoveries of 99.81±0.64 and 100.53±1.11, respectively. The third method is pH-induced difference method for determination of OLA in presence of its acidic and alkaline degradation products; with mean percentage recoveries 100.09±0.06 and 99.77±0.78, respectively. Fourth method is the Q-analysis (absorption ratio) method, which involves the formation of absorbance equation at 296.3 nm (isosbestic point) and 271 nm (λmax of OLA) for the determination of OLA in presence of its acidic degradation products. The mean percentage recovery is 100.07±1.51. Fifth method based on dual wavelength selection was developed for the determination of OLA in presence of its acidic degradation products with mean percentage recovery of 100.36±0.69. Sixth method based on simple mathematic algorithm by the bivariate calibration was also used for the determination of OLA with the mean percentage recovery of 101.72±1.10. The second technique is chemometrics, which includes determination of OLA in presence of its acidic degradation products using multivariate calibration methods (the classical least squares (CLS), principle component regression (PCR) and partial least squares (PLS)) using the information contained in the absorption spectra.


icon graph This Abstract was viewed 1654 times | icon graph Article PDF downloaded 770 times

How to Cite
(1)
Hussien, L. A. E. A.; Ghani, M. F. A.; El-Alamein, A. M. A.; Mohamed, E. H. Stability-Indicating Methods for the Determination of Olanzapine in Presence of Its Degradation Products. Eur. J. Chem. 2014, 5, 311-320.

Article Details

Share
Crossref - Scopus - Google - European PMC
References

[1]. David, B.; Beringer, P. Remington: The Science and Practice of Pharmacy, 21th Edition, Lippincott Williams & Wilkins, 2006.

[2]. Nagaraju, K. B.; Kanakapura, R.; Vinay, B. Chem. Ind. Chem. Eng. Q 2009, 15(2), 77-81.
http://dx.doi.org/10.2298/CICEQ0902077B

[3]. Basavaiah, K.; Abdulrahman, S. M. Int J. Chem. Tech. Res. 2010, 2(1), 660-680.

[4]. Firdous, S.; Aman, T.; Nisa, A. J. Chem. Soc. Pakistan 2005, 27(2), 163-167.

[5]. Basavaiah, K.; Tharpa, K.; Ragendraprasad, N.; Hiriyanna, S. G.; Vinay, K. B. Jordan J. Chem. 2009, 4(1), 65-76.

[6]. Basavaiah, K.; Abdulrahman, S. M.; Vina,y K. B. J. Food Drug Anal. 2009, 17(6), 434-442.

[7]. Ragendraprasad, N.; Basavaiah, K. Braz. J. Pharm. Sci. 2009, 45(3), 539-550.
http://dx.doi.org/10.1590/S1984-82502009000300020

[8]. Basavaiah, K.; Zenita, O.; Tharpa, K.; Rajendraprasad, N.; Anilkumar, U. R.; Hiriyana, S. G.; Vinay, K. B. Chem. Ind. Chem. Eng. Q 2009, 15(2), 95-102.
http://dx.doi.org/10.2298/CICEQ0902095B

[9]. Revanasiddappa, H. D.; Veena, M. A. Eclet. Quim. 2008, 33(3), 47-52.
http://dx.doi.org/10.1590/S0100-46702008000300007

[10]. Rajendraprasad, N.; Basavaiah, K. J. Anal. Chem. 2010, 65(5), 482-488.
http://dx.doi.org/10.1134/S1061934810050084

[11]. Krebs, A.; Starczewska, B.; Tarasiewicz, H.; Sled, P. J. Anal. Sci. 2006, 22(6), 829-833.
http://dx.doi.org/10.2116/analsci.22.829

[12]. Mohamed, A. Chem. Mater. Sci. 2008, 139(9), 1005-1010.

[13]. Jasinska, A.; Nalewajko, E. Anal. Chim. Acta 2004, 508(2), 165-170.
http://dx.doi.org/10.1016/j.aca.2003.11.069

[14]. Basavaiah, K.; Abdulrahman, S. M.; Vinay, K. B. Jordan J. Chem. 2010, 5(1), 101-117.

[15]. Rajendraprasad, N.; Basavaiah, K.; Tharpa, K.; Vinay, K. B. Eurasian J. Anal. Chem. 2009, 4(2), 191-203.

[16]. Patel, V. M.; Patel, J. A.; Havele, S. S.; Dhaneshwar, S. R. Int. J. Chem. Tech. Res. 2010, 2(1), 756-761.

[17]. Biryol, I.; Erk, N. Anal. Lett. 2003, 36(11), 2497-2513.
http://dx.doi.org/10.1081/AL-120024338

[18]. Raggi, M. A.; Casamenti, G.; Mandrioli, R.; Izzo, G.; Kenndler, E. J. Pharmaceut. Biomed. 2000, 23(6), 973-981.
http://dx.doi.org/10.1016/S0731-7085(00)00382-4

[19]. Belal, F.; El-Brashy, A.; El-Enany, N.; El-Bahay, N. J. AOAC Int. 2008, 91(6), 1309-1317.

[20]. Patel, S.; Patel, N. J. Indian J. Pharm. Sci. 2009, 71(4), 477-480.
http://dx.doi.org/10.4103/0250-474X.57306

[21]. Shah, C. R.; Shah, N. J.; Suhagia, B. N.; Patel, N. M. J. AOAC Int. 2007, 90(6), 1573-1578.

[22]. Patel, K. S.; Patel, N. J.; Patel, U. P.; Patel, B. D.; Patel, A. S.; Prajapati, M. U. J. Planar Chrom. 2009, 22(2), 121-126.
http://dx.doi.org/10.1556/JPC.22.2009.2.8

[23]. Saxena, V.; Zaheer, Z.; Farooqui, M. Asian J. Chem. 2006, 18(2), 1212-1222.

[24]. Shah, C. R.; Suhagia, B. N.; Shah, N. J.; Patel, D. R.; Patel, N. M. Indian J. Pharm. Sci. 2008, 70(2), 251-255.
http://dx.doi.org/10.4103/0250-474X.41469

[25]. Mohammadi, A.; Amini, M.; Hamedani, M. P.; Torkabadi, H. H.; Walker, R. B. Asian J. Chem. 2008, 20(7), 5573-5580.

[26]. Saracino, M. A.; Gandolfi, O.; Dall'Olio, R.; Albers, L.; Kenndler, E.; Raggi, M. A. J. Chromatogr. A 2006, 1122(1-2), 21-27.
http://dx.doi.org/10.1016/j.chroma.2006.04.011

[27]. Zhang, G.; Terry, A. V.; Bartlett, M. G. J. Chromatogr. B 2007, 858(1-2), 276-281.
http://dx.doi.org/10.1016/j.jchromb.2007.08.007

[28]. Ole, V. O.; Linnet, K.; Kristian, D. L. J. Chromatogr. B 1998, 714(2), 309-315.
http://dx.doi.org/10.1016/S0378-4347(98)00205-9

[29]. Tang, Y.; Song, W.; Wu, L. Zhogguo Yaoye 2007, 16(21), 46-47.

[30]. Xia, Y.; Jiang, K.; Wu, A.; Li, H. Zhongguo Yaoxue Zazhi 2002, 37(3), 215-217.

[31]. D'Arrigo, C.; Migliardi, G.; Santoro, V. Ther. Drug Monit. 2006, 28(3), 388-393.
http://dx.doi.org/10.1097/01.ftd.0000211800.66569.c9

[32]. Titier, K.; Bouchet, S.; Pehourcq, F.; Moore, N.; Molimard, M. J. Chromatogr. B 2003, 788(1), 179-185.
http://dx.doi.org/10.1016/S1570-0232(02)01003-6

[33]. Kobylinska, K.; Bus, K. M.; Kiliszek, M. B. Acta Pol. Pharm. 2008, 65(6), 759-762.

[34]. Aravagiri, M.; Teper, Y.; Marder, R. Biopharm. Drug Dispos. 1999, 20(8), 369-377.
http://dx.doi.org/10.1002/1099-081X(199911)20:8<369::AID-BDD200>3.0.CO;2-6

[35]. Dusci, J. L.; Hackett, L. P.; Fellows, L. M.; Ilett, K. F. J. Chromatogr. B 2002, 773(2), 191-197.
http://dx.doi.org/10.1016/S1570-0232(02)00164-2

[36]. Raggi, M. A.; Mandrioli, R.; Sabbioni, C.; Ghedini, N.; Fanali, S.; Volterra, V. Chromatographia 2001, 54(3-4), 203-207.
http://dx.doi.org/10.1007/BF02492246

[37]. Llorca, M. P.; Coudore, F.; Corpelet, C.; Buyens, A.; Hoareau, M.; Eschalie,r A. Fr. Clinical Chemistry 2001, 47(9), 1719-1721.

[38]. Berna, M.; Ackermann, B.; Ruterbories, K.; Glass, S. J. Chromatogr. B 2002, 767(1), 163-168.
http://dx.doi.org/10.1016/S0378-4347(01)00548-5

[39]. Saracino, M. A.; Gandolfi, O.; Dall'Olio, R.; Albers, L.; Kenndler, E.; Raggi M. A. J. Chromatogr A 2006, 1122(1-2), 21-27.
http://dx.doi.org/10.1016/j.chroma.2006.04.011

[40]. Josefsson, M.; Roman, M.; Skogh, E.; Dahl, M. J. Pharmaceut. Biomed. 2010, 53(3), 576-582.
http://dx.doi.org/10.1016/j.jpba.2010.03.040

[41]. Kasper, C.; Mattiuz, E. L.; Swanson, S. P.; Chiu, J. A.; Johnson, J. T.; Garnera, C. O. J. Chromatogr B, 1999, 726(1-2), 203-209.
http://dx.doi.org/10.1016/S0378-4347(99)00017-1

[42]. Rao, R. N.; Raj, A. N.; Narsimha, R.; Babu, G. B. J. Sep. Sci. 2008, 31(1), 107-118.
http://dx.doi.org/10.1002/jssc.200700397

[43]. Rani, P.; Sekaran, B. Int. J. Pharm. Tech. Res. 2009, 1(3), 654-657.

[44]. Basavaiah, K.; Rangachar, A. K. U.; Tharpa, K. J. Mex. Chem. Soc. 2008, 52(2), 120-124.

[45]. Rani, A. P.; Sekaran, C. B. Int. J. Pharm. Tech. Res. 2009, 1(3), 654-657.

[46]. Reddy, B. V.; SureshReddy, K. V.; Sreeramulu, J.; Kanumula, G. V. Chromatographia 2007, 66(1-2), 111-114.
http://dx.doi.org/10.1365/s10337-007-0257-z

[47]. Weigmann, H.; Hartter, S.; Maehrlei, S.; Kiefer, W.; Kräamer, G.; Dannhardt, G.; Hiemke, C. J. Chromatogr. B 2001, 759(1), 63-71.
http://dx.doi.org/10.1016/S0378-4347(01)00215-8

[48]. Zhang, G.; Terry, A. V.; Bartlett, M. G. J. Chromatogr, B 2007, 856(1-2), 20-28.
http://dx.doi.org/10.1016/j.jchromb.2007.05.015

[49]. Sachsea, J.; Kollerb, J.; Haertter, S.; Hiemke, C. J. Chromatogr. B 2006, 830(2), 342-348.
http://dx.doi.org/10.1016/j.jchromb.2005.11.032

[50]. Li, W.; Zhai, Y.; Wang, C.; Qin, Y.; Weng Y. Sepu 2000, 18(6), 550-553.

[51]. Bogusz, M. J.; Kruger, K. D.; Maier, R. D.; Erkwoh, R. J. Chromatogr. B 1999, 732(2), 257-269.
http://dx.doi.org/10.1016/S0378-4347(99)00287-X

[52]. Zhou, Z.; Li, X.; Li, K.; Xie, Z.; Cheng, Z.; Peng, W.; Wang, F.; Zhu, R.; Li, H. J. Chromatogr. B 2004, 802(2), 257-262
http://dx.doi.org/10.1016/j.jchromb.2003.11.037

[53]. Pathak, A.; Rajput, S. J. J. Chromatogr. Sci. 2009, 47(7), 605-611.
http://dx.doi.org/10.1093/chromsci/47.7.605

[54]. Harvey, E. J.; Flanagan, R. J.; Taylor, D. M. Pharm. J. 2000, 265(70), 275-276.

[55]. Rao, P. S.; Ray, U. K.; Hiriyanna, S. G.; Rao, S. V.; Sharma, H. K.; Handa, V. K.; Mukkanti, K. J. Pharmaceut. Biomed. 2011, 56(2), 413-418.
http://dx.doi.org/10.1016/j.jpba.2011.05.003

[56]. Krishnaiaha, C.; Murthya, M. V.; Kumara, R.; Mukkantib, K. J. Pharmaceut. Biomed. 2011, 54, 667-673.
http://dx.doi.org/10.1016/j.jpba.2010.10.013

[57]. Hiriyanna, S. G.; Basavaiah, K.; Goud, P. S. K.; Dhayanith, V.; Raju, K.; Pati, H. N. Acta Chromatogr. 2008, 20(1), 81-93.
http://dx.doi.org/10.1556/AChrom.20.2008.1.7

[58]. Jenkins, A. J.; Sarconi, K. M.; Raaf, H. N. J. Anal Toxicol. 1988, 22(7), 605-609.
http://dx.doi.org/10.1093/jat/22.7.605

[59]. Suslu, I.; Altınoz, S.; Erdal, D.; Baleanu, D. Int. Works. New Trends Sci. Tech. November, 2008, Ankara, Turkey, http://ntst08.cankaya.edu.tr/proceedings/proceedings/IncilaySusluPaper.pdf, Online: 02/17/2014.

[60]. Ni, Y.; Gong, X. Anal. Chim. Acta 1997, 354, 163-171.
http://dx.doi.org/10.1016/S0003-2670(97)00297-3

[61]. ICH, Q2 (R1), Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonization, Geneva, Switzerland 2005.

[62]. Salinas, F.; Berzas, J. J.; Espinosa, M. A. Talanta 1990, 37(3), 347- 351.
http://dx.doi.org/10.1016/0039-9140(90)80065-N

[63]. Shevchenko, V. P.; YuNagaev, I.; Kost, N. V.; Ivanov, I. A. Dokl. Chem. 2010, 434, 260-262.
http://dx.doi.org/10.1134/S0012500810100034

[64]. Chitlange, S. S.; Ranjana, S.; Wankhede, S. B.; Kulkarni, A. A. Int. J. Chem. Tech Res. 2009, 1(2), 135-138.

[65]. Dhabale, P. N.; Bhagade, S. R. J. Chem. Pharm. Res. 2011, 3(2), 650-656.

[66]. Fernandes, N.; Nimdeo, M. S.; Choudhari, V. P.; Kulkarni, R. R.; Pande, V.; Nikalje, A. G. Int. J. Chem. Sci. 2008, 6(1), 29-35.

[67]. Lopez-Martinez, L.; Lopez-de-Alb, P. L.; Creda-Martin, V. Anal. Lett. 2001, 34(14), 2563- 2583.
http://dx.doi.org/10.1081/AL-100107536

[68]. Massart, D. L.; Vandeginsite, B. G. M.; Deming, S. N.; Michotte, Y.; Kaufman, L. Chemometrics: a textbook, El-Servier, Amsterdam, 1988.

[69]. Lopez-de-Alba, P. L.; Wrobel, K.; Lopez-Martinez, L.; Yepez-Murrieta, M. L.; Amador-Hernandez, J. J. Pharmaceut. Biomed. 1997, 16, 349-355
http://dx.doi.org/10.1016/S0731-7085(97)00068-X

[70]. Haaland, D. M.; Thomas, E. V. Comparison of multivariate calibration methods for quantitative spectral analysis. Anal. Chem. 1990, 62, 1091-1099.
http://dx.doi.org/10.1021/ac00209a024

[71]. Kenneth, R. B.; Randy, J. P.; Seasholtz, M. B. Chemometrics: A Practical Guide, New York: John Wiley and Sons Inc. 1998.

Supporting Agencies

Most read articles by the same author(s)
TrendMD

Dimensions - Altmetric - scite_ - PlumX

Downloads and views

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...
License Terms

License Terms

by-nc

Copyright © 2024 by Authors. This work is published and licensed by Atlanta Publishing House LLC, Atlanta, GA, USA. The full terms of this license are available at https://www.eurjchem.com/index.php/eurjchem/terms and incorporate the Creative Commons Attribution-Non Commercial (CC BY NC) (International, v4.0) License (http://creativecommons.org/licenses/by-nc/4.0). By accessing the work, you hereby accept the Terms. This is an open access article distributed under the terms and conditions of the CC BY NC License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited without any further permission from Atlanta Publishing House LLC (European Journal of Chemistry). No use, distribution, or reproduction is permitted which does not comply with these terms. Permissions for commercial use of this work beyond the scope of the License (https://www.eurjchem.com/index.php/eurjchem/terms) are administered by Atlanta Publishing House LLC (European Journal of Chemistry).